Introduction
The prevalence of Congestive Heart Failure (CHF) has been increasing globally because of the aging population and the increased risk factors such as lung disease, diabetes mellitus, hyperlipidemia, and hypertension. It is estimated that over 6.5 million Americans over 20 years have heart failure (Clark et al., 2022). According to the American Heart Association, this number is projected to increase by 46% by 2030. It is crucial to note that heart failure (HF) is a leading cause of high hospitalization rates among people aged 65 years and older, with more than 1 million hospital admissions in the US annually. The estimated cost of HF care in America is more than $30 billion annually, including direct and indirect medical costs such as lost productivity and disability (Clark et al., 2022). Joshi and Nair (2021) note that HF is the main cause of 30-day hospital readmissions in the US. These frequent hospital readmissions are largely associated with increased mortality, healthcare costs, and poor quality of life. For instance, the prognosis for HF is poor, with a 5-year mortality rate of approximately 50% (Joshi & Nair, 2021). Considering all these statistics, this topic was selected to improve HF patients’ quality of life and overall health, as observed in my clinical rotation with the Heart Success Program. It is crucial to note that frequent hospital readmissions increase the risk of hospital-acquired infections and healthcare expenses. They limit patients’ time with their families and work, leading to poor quality of life.
PICO Question
The PICO question selected for this paper is:
P- In adults with chronic systolic and/or diastolic heart failure
I- Is the utilization of CardioMEMS, a hemodynamic monitoring system, effective.
C- Compared to conventional guideline-directed medical therapy
O- In reducing Heart Failure related hospital readmissions.
In the above PICO Question, the population of interest is adults with chronic systolic and/or diastolic heart failure. The intervention being considered is using CardioMEMS, a hemodynamic monitoring system implanted into a patient’s pulmonary artery to monitor their pressure and continuously transmit data to healthcare providers. Hemodynamic monitoring systems, such as CardioMEMS, have been developed to improve heart failure management through real-time pulmonary artery pressure monitoring. These can help guide treatment decisions and prevent exacerbations that may lead to hospitalization. The comparison is with conventional guideline-directed medical therapy, which includes medications, lifestyle changes, and other treatments recommended by guidelines to manage heart failure. The outcome of interest is the reduction of heart failure-related hospital readmissions, which is a key metric for evaluating the effectiveness of heart failure treatments. Overall, the resulting question aims to inform clinical decision-making and guide the development of evidence-based practice guidelines for heart failure management.
Methods
Several databases were used to identify the relevant articles that can be used to answer the clinical question, including Embase, MEDLINE/ PubMed, CINAHL, and Cochrane Library. In the search, keywords were used, including “CardioMEMS,” “pulmonary artery pressure monitoring,” “heart failure,” and “hospital readmissions.” Once the relevant keywords and databases were identified, a search query was constructed. Specifically, the Boolean operator “AND” combined the keywords to create a specific search query tailored to our PICO question. For example, the following search query was used: “CardioMEMS AND pulmonary artery pressure monitoring AND heart failure AND hospital readmissions.” Additional search terms or synonyms were added to the query to refine the search. For example, the synonyms for heart failure, such as “systolic heart failure” or “diastolic heart failure,” were used. In addition, alternative phrases for hospital readmissions, such as “re-hospitalization,” were also used. This paper focused on recent and up-to-date articles to limit the search. In addition, the search only includes articles published using English and full-text. All those that did not meet this inclusion criterion were excluded. Notably, those that did not address the clinical question were excluded.
After the search, 15 articles met the inclusion criteria, but two articles were selected because of their relevance to the clinical question. The first article selected was “Champion trial rationale and Design: The long-term safety and clinical efficacy of a wireless pulmonary artery Pressure Monitoring System” by Adamson et al. (2011). This article was selected for this PICO question because it provides a detailed description of the Champion trial, a large, multicenter RCT that evaluated the clinical efficacy and safety of the CardioMEMS in HF patients. In addition, the article provides important information on the patient population, intervention, and outcomes of the trial, including heart failure hospitalizations, which is the main outcome of interest in the PICO question. The article also describes the study design and methods, which are important for evaluating the quality and validity of the study.
The second article selected is “The Utility of CardioMEMS, a wireless hemodynamic monitoring system in Reducing Heart Failure Related Hospital Readmissions” by Joshi and Nair (2021). This article was selected for this PICO question because it specifically addresses the utilization of CardioMEMS in decreasing HF-related hospital readmissions, which is the primary outcome of interest in the PICO question. The article provides a comprehensive review of the current literature on using CardioMEMS for heart failure management, including its impact on heart failure hospitalizations. Furthermore, the article provides an up-to-date analysis of recent studies that have researched the effectiveness of CardioMEMS in reducing heart failure-related hospital readmissions, which is directly relevant to the PICO question. The article also provides insights on the potential benefits and limitations of using CardioMEMS for heart failure management, which is valuable information for healthcare providers and patients considering this technology.
Article Review
The study by Adamson et al. (2011) sought to investigate the clinical efficacy and safety of the CardioMEMS so that it can be used to manage HF patients. The study was conducted between 2007 and 2009 and enrolled 550 patients with New York Heart Association (NYHA) class III HF. The Champion trial was designed to assess whether using the CardioMEMS device, which measures pulmonary artery pressure and heart rate, could reduce the rate of HF hospitalizations compared to conventional therapy alone (Adamson et al., 2011). In this study, the patients were assigned randomly to either the CardioMEMS or the control group, with the control group receiving traditional disease management of HF.
According to this study, the CHAMPION trial could establish the use of the CardioMEMS system as a new paradigm for managing symptomatic HF patients. The system enables early detection of worsening HF and allows for prompt intervention, which may reduce hospitalizations and improve outcomes. If the trial demonstrates the clinical efficacy and safety of the system, it could lead to significant changes in HF management, improving patient outcomes and reducing healthcare costs (Adamson et al., 2011). The study revealed that CardioMEMS was safe and well-tolerated, with no major device-related adverse events reported. Regarding the study’s methodology, the Champion trial was a well-designed and well-conducted randomized controlled trial that followed a rigorous protocol and included a large patient population. However, the study had some limitations, including a lack of blinding and a relatively short follow-up period (Adamson et al., 2011). Despite these limitations, the study was well-conducted and considered high-quality evidence according to the GRADE system.
In the other study by Joshi and Nair (2021), the authors aimed to inform healthcare professionals about using CardioMEMS to reduce hospital readmission rates from heart failure. According to this article, hospital readmissions due to heart failure exacerbations are associated with increased healthcare costs, poor quality of life, and increased mortality. The authors argue that CardioMEMS wireless pulmonary artery pressure monitoring systems have proved to be a promising tool in monitoring and managing HF and reducing frequent and early readmissions related to HF. The CHAMPION trial demonstrated a 37% reduction in heart failure-related hospitalization during the 15-18 months follow-up period (Joshi & Nair, 2021). This technology allows for early detection of worsening heart failure and enables prompt intervention, which may prevent hospitalizations and improve outcomes. By decreasing constant hospitalizations and 30-day rates of readmission, the CardioMEMS system has the potential to improve quality of life, decrease morbidity and mortality, and reduce the cost of healthcare (Joshi & Nair, 2021). The authors concluded that CardioMEMs technology might establish a new paradigm for heart failure management, enabling more effective and efficient care for HF patients.
Discussion
As noted earlier, HF is a common chronic condition characterized by the inability of a person’s heart to pump enough blood to meet the body’s needs properly. It is a leading cause of readmission and hospitalization in adults, with a significant burden on healthcare resources. According to Davidson & Allison (2017), Guideline-directed medical therapy (GDMT) is key to HF management. However, the optimal and effective management of HF patients remains challenging, and hospital readmissions are frequent. The development of novel strategies to reduce HF-related hospitalizations has gained attention in recent years, and one of these strategies is the utilization of the CardioMEMS hemodynamic monitoring system. In this paper, we aim to demonstrate a thorough and sophisticated understanding of the effectiveness of CardioMEMS compared to conventional GDMT in reducing HF-related hospital readmissions in adults with chronic systolic or diastolic HF.
Multiple studies have investigated the use of CardioMEMS in HF management, and the overall evidence suggests that this system effectively reduces HF-related hospital readmissions. For example, the CHAMPION trial demonstrated that using CardioMEMS reduced HF-related hospitalizations by 28% compared to conventional GDMT alone (Adamson et al., 2011). Additionally, the CardioMEMS post-approval study, a real-world registry, reported a significant reduction in HF-related hospitalizations among patients using CardioMEMS compared to those receiving conventional GDMT (Bhatia & Maddox, 2021). These findings were consistent with several smaller studies that also demonstrated the effectiveness of CardioMEMS in reducing HF-related hospitalizations (Veenis & Brugts, 2020; Cowie et al., 2017).
According to Veenis & Brugts (2020), CardioMEMS is a hemodynamic monitoring system that allows for remote monitoring of pulmonary artery pressures, a key indicator of HF exacerbation. The system consists of a small sensor implanted in the pulmonary artery, which transmits pressure data to a receiver in the patient’s home. Clinicians can then access the data and adjust treatment as needed. CardioMEMS allows for early detection of worsening HF and early interventions to prevent hospitalization (Veenis & Brugts, 2020). This is particularly important given the higher hospital readmissions in HF patients, which are associated with poor outcomes, increased healthcare costs, and reduced quality of life. In addition to reducing hospital readmissions, using CardioMEMS has been associated with other benefits in HF management. For example, a study by Cowie et al. (2017) reported that using CardioMEMS was linked with significantly improving patient well-being and quality of life. Additionally, the CHAMPION trial demonstrated a decrease in HF-related healthcare costs among patients using CardioMEMS (Cowie et al., 2017). These findings suggest that CardioMEMS may have broader benefits beyond reducing hospital readmissions.
Despite the evidence supporting the effectiveness of CardioMEMS in reducing HF-related hospital readmissions, adopting this technology could be faster. According to Pour-Ghaz et al. (2019), this may be due to increasing concerns about the system’s cost-effectiveness and the need for specialized training and infrastructure to implement the system effectively. However, recent studies have suggested that the cost-effectiveness of CardioMEMS may be comparable to other interventions commonly used in HF management, such as implantable cardioverter defibrillators (ICDs) (Pour-Ghaz et al., 2017). Additionally, advances in telemedicine and remote monitoring may make the implementation of CardioMEMS more feasible and cost-effective in the future.
Based on the evidence presented, we recommend using CardioMEMS in managing adults with chronic systolic and/or diastolic HF, particularly those at high risk for hospital readmission. Clinicians should consider incorporating this technology into their HF management plans, particularly for patients with hospitalizations or frequent emergency department visits for HF exacerbation. Patients should also be educated on the benefits of CardioMEMS and encouraged to participate in remote monitoring to enable early detection of worsening HF. It is worth noting that using CardioMEMS should not replace conventional GDMT, which remains the cornerstone of HF management. Rather, CardioMEMS should be used as an adjunct to GDMT to enable early detection of worsening HF and prompt intervention. Additionally, the long-term effects of CardioMEMS on HF outcomes are still being studied. Further research must determine the optimal timing and duration of CardioMEMS use in HF management.
Conclusion
In conclusion, it is undeniable that HF remains one of the leading causes of hospitalization and hospital readmissions and significantly impacts patients’ quality of life, healthcare costs, and mortality rates. It is, therefore, imperative to identify interventions that can improve the management of HF and reduce hospital readmissions. CardioMEMS, a hemodynamic monitoring system, is a potential intervention for HF management that can lead to better patient outcomes. Specifically, using CardioMEMS is a promising strategy to reduce HF-related hospital readmissions in adults with chronic systolic and/or diastolic HF. Clinicians should consider incorporating this technology into their HF management plans, particularly for high-risk patients, and patients should be educated on the benefits of remote monitoring. However, further research is needed to fully understand the long-term effects and optimal use of CardioMEMS in HF management.
References
Adamson, P. B., Abraham, W. T., Aaron, M., Aranda Jr, J. M., Bourge, R. C., Smith, A., & Yadav, J. S. (2011). CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. Journal of cardiac Failure, 17(1), 3-10. https://pubmed.ncbi.nlm.nih.gov/21187258/
Bhatia, A., & Maddox, T. M. (2021). Remote patient monitoring in heart failure: factors for clinical efficacy. International Journal of Heart Failure, 3(1), 31-50.
Clark, K. A., Reinhardt, S. W., Chouairi, F., Miller, P. E., Kay, B., Fuery, M., & Desai, N. R. (2022). Trends in Heart Failure Hospitalizations in the US from 2008 to 2018. Journal of Cardiac Failure, 28(2), 171-180.
Cowie, M. R., Simon, M., Klein, L., & Thokala, P. (2017). The cost‐effectiveness of real‐time pulmonary artery pressure monitoring in heart failure patients: a European perspective. European journal of heart failure, 19(5), 661-669.
Davidson, B. T., & Allison, T. L. (2017). Improving heart failure patient outcomes utilizing guideline-directed therapy. The Nurse Practitioner, 42, 3-14.
Joshi, R., & Nair, A. (2021). The utility of CardioMEMS, a wireless hemodynamic monitoring system in reducing heart failure-related hospital readmissions. The Journal for Nurse Practitioners, 17(3), 267-272. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7954281/
Pour-Ghaz, I., Hana, D., Raja, J., Ibebuogu, U. N., & Khouzam, R. N. (2019). CardioMEMS: where we are and where can we go? Annals of translational medicine, 7 (17).
Schmier, J. K., Ong, K. L., & Fonarow, G. C. (2017). Cost‐effectiveness of remote cardiac monitoring with the CardioMEMS heart failure system. Clinical cardiology, 40(7), 430-436.
Veenis, J. F., & Brugts, J. J. (2020). Remote monitoring for better management of LVAD patients: the potential benefits of CardioMEMS. General thoracic and cardiovascular surgery, 68(3), 209-218.
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